(73 days)
Not Found
No
The device description and intended use clearly describe a mechanical drill bit for bone, with no mention of software, algorithms, or any AI/ML related terms.
No
The device is described as drill bits used for drilling holes in bone during various surgical procedures. Its function is to create passages, not to treat or alleviate a disease, injury, or medical condition directly. Tools used to facilitate surgical procedures are typically considered surgical instruments, not therapeutic devices.
No
Explanation: The device is described as a drill for making holes in bone during surgical procedures, which is an operative function, not a diagnostic one.
No
The device description clearly states it is a physical drill bit, which is a hardware component, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Lorenz Twist Drills Function: The Lorenz Twist Drills are surgical tools used directly on the bone within the body during surgical procedures. They are used for mechanical action (drilling holes), not for analyzing biological specimens.
The provided information clearly describes a surgical instrument, not a diagnostic test performed on samples.
N/A
Intended Use / Indications for Use
The Lorenz Twist Drills are intended to be used for drilling holes in large and small bone during orthopedic, spinal, neurosurgical, medial sternotomy, and oral and maxillofacial procedures.
Product codes
HBE
Device Description
Lorenz Twist drills are drill bits which can either be attached to a manual instrument handle or attached to a powered handpiece/drill motor and used to drill holes in bone.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
large and small bone
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Linvatec PowerPro Pneumatic System K032607, Stryker Oral Max System K954690
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 882.4310 Powered simple cranial drills, burrs, trephines, and their accessories.
(a)
Identification. Powered simple cranial drills, burrs, trephines, and their accessories are bone cutting and drilling instruments used on a patient's skull. The instruments are used with a power source but do not have a clutch mechanism to disengage the tip after penetrating the skull.(b)
Classification. Class II (performance standards).
0
Ya62842
Image /page/0/Picture/1 description: The image shows the logo for W. Lorenz Surgical, a Bionet Company. The logo is in black and white, with the words "W. Lorenz" in large, bold letters. Below that, the word "Surgical" is written in smaller letters. Underneath the word "Surgical" is the phrase "A Bionet Company".
510(k) Summary
1520 Tradeport Drive Jacksonville, FL 32218 904-741-4400 fax 904-741-4500
Device Name: Lorenz Twist Drills
JEC - 4 2006
Classification Name and Reference:
CFR 882.4300 Manual cranial drills, burrs, trephines, and their accessories CFR 882.4310 Powered simple cranial drills, burrs, trephines, and their accessories CFR 872.4120 Bone cutting instrument and accessories CFR 878.4800 Manual surgical instrument for general use CFR 878.4820 Surgical instrument motors and accessories CFR 888.4540 Orthopedic manual surgical instrument
Device Classification: Class II, Class I
Device Description: Lorenz Twist drills are drill bits which can either be attached to a manual instrument handle or attached to a powered handpiece/drill motor and used to drill holes in bone.
Intended Use: The Lorenz Twist Drills are intended to be used for drilling holes in large and small bone during orthopedic, spinal, neurosurgical, medial sternotomy, and oral and maxillofacial procedures.
Materials: Stainless Steel
Possible Adverse Effects:
-
- Metal sensitivity reactions or allergic reaction to the implant material.
-
- Pain, discomfort, or abnormal sensation due to the presence of the device.
-
- Surgical trauma; permanent or temporary nerve damage, permanent or temporary damage to heart, lungs, and other organs, body structures or tissues.
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- Skin irritation, infection, and pneumothorax.
-
- Fracture, breakage, migration, or loosening of the implant.
-
- Inadequate or incomplete remodeling of the deformity or return of deformity, prior to or after removal of implant.
-
- Permanent injury or death.
Substantial Equivalence
W. Lorenz considers the Lorenz Twist drills equivalent to the existing Twist drills which are classified as class I devices. W. Lorenz twist drills are also equivalent to Linvatec PowerPro Pneumatic System K032607 and Stryker Oral Max System K954690.
1
Public Health Service
Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes forming its wing. The eagle faces right and is positioned above the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Walter Lorenz Surgical, Inc. % Ms. Kim Reed Sr. Regulatory Specialist 1520 Tradeport Drive Jacksonville, Florida 32218
DEC - 4 2006
Re: K062842
Trade/Device Name: Lorenz Twist Drills Regulation Number: 21 CFR 882.4310 Regulation Name: Powered simple cranial drills, burrs, trephines, and their accessories Regulatory Class: II Product Code: HBE Dated: November 17, 2006 Received: November 22, 2006
Dear Ms. Reed:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
2
Page 2 – Ms. Kim Reed
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Saubare Mueller
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known): K062842
Device Name: Lorenz Twist Drills
Indications For Use: The Lorenz Twist Drills are intended to be used for drilling holes in large and small bone during orthopedic, spinal, neurosurgical, medial sternotomy, and oral and maxillofacial procedures.
Prescription Use xx_______________________________________________________________________________________________________________________________________________________
Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Barbara Buell
Page 1 of
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K06284